OVERVIEW
The pharmaceutical industry continues to experience decreasing productivity and high levels of attrition. Inflation of molecule physicochemical properties and complexities in clinical trial protocols stand among the main reasons for these trends. The most successful companies can leverage different expertise, manage risks, and follow logical sequences of operations in an integrated manner to speed development.
Hosted by the Catalent Applied Drug Delivery Institute, with the Department of Pharmaceutical Sciences (DISFARM), University of Milan, and Leads to Development, this webinar will focus on the key considerations for transitioning a molecule from discovery through clinical studies including molecule developability assessment, phase-appropriate formulation selection, integration of product development and clinical supply as well as regulatory requirements for advancing a developmental candidate to clinical trials.
The Catalent Applied Drug Delivery Institute brings together pharmaceutical innovators, organizations, and academia to improve clinical outcomes, medication delivery profiles, patient adherence and treatment efficacy.
AGENDA:
Introduction
Alessandra Mengoni, Account Director, Catalent
Dr. Roberto Tiezzi, Director, Open Innovation & Knowledge Transfer Unit, University of Milan
Dr. Paola Minghetti, Professor, DISFARM, University of Milan
Strategies to De-risk Early Drug Development
Stephen Tindal, Director, Science & Technology, Catalent
- Molecule developability assessment
- Phase-appropriate formulation: When advanced technologies are required versus simplified approaches
- How to ensure a commercially viable manufacturing process and formulation when transitioning beyond Phase II clinical trial
- Efficient coordination of manufacturing, packaging, storage and distribution for early-stage clinical development
Impact of Formulation and Process in Drug Development and Delivery
Francesca Selmin, Ph.D., Associate Professor, Department of Pharmaceutical Sciences (DISFARM), University of Milan
- Biopharmaceutical considerations in drug formulation design
- Understanding the importance of pharmaceutical processing, formulation and their interaction on the solid-state transition of drug substances and excipients
Navigating Through Drug Development Process with a Proven Regulatory Strategy
Julien Massiot, Ph.D., Project Manager, Leads To Development (L2D)
- Overview of non-clinical development strategy (Pharmacology, CMC, ADME, toxicology)
- Enabling drug candidates to enter clinical development successfully and rapidly
- Anticipating regulatory expectations for your clinical trial application
